Nghị quyết 168/NQ-CP năm 2021 về cơ chế, chính sách trong phòng, chống dịch COVID-19 do Chính phủ ban hành

RESOLUTION

ON A NUMBER OF MECHANISMS AND POLICIES ON COVID-19 PREVENTION AND CONTROL

THE GOVERNMENT OF VIETNAM

Pursuant to the Law on Government Organization of Vietnam dated June 19, 2015; the Law on amendments to some articles of the Law on Government Organization of Vietnam and Law on Local Government Organization of Vietnam dated November 22, 2019;

Pursuant to Resolution No. 30/2021/QH15 dated July 28, 2021 of the 1st session of the 15th National Assembly

Pursuant to the Government’s Decree No. 138/2016/ND-CP dated October 01, 2016 on working regulation of the Government of Vietnam;

Pursuant to the Government’s Resolution No. 86/NQ-CP dated August 6, 2021 on urgent solutions for COVID-19 prevention and control to implement resolution No 30/2021/QH15 dated July 28, 2021 of the 1st session of the 15th National Assembly ;

At the request of the Minister of Health of Vietnam and with the agreement of members of the Government of Vietnam,

HEREBY RESOLVES:

The COVID-19 epidemic in Vietnam is unpredictable and it is seriously threatening people's health and lives. It is necessary and urgent to ensure the conditions for the COVID-19 prevention and control in terms of drugs, vaccines and medical equipment. The Government resolves a number of special mechanisms and policies on COVID-19 prevention and control to implement Resolution No. 30/2021/QH15 dated July 28, 2021 of the 1st session of the 15th National Assembly with the following basic contents:

Article 1. COVID-19 treatment facilities

1. The COVID-19 treatment facilities are facilities where receive, manage, take care of and treat people who are confirmed COVID-19 inspection according to one of the following organization forms:

a) The facilities are established to treat people who are confirmed COVID-19 inspection including: field hospitals; hospitals; resuscitation & emergency hospitals; intensive care centers; mobile medical stations;

b) Rooms, departments and units of treatment facilities are responsible for treatment of people confirmed COVID-19 inspection;

c) Other organization forms.

2. The authority to establish and assign tasks shall comply with the regulations of Clause 2, Article 2 of the Government’s Resolution No. 86/NQ-CP dated August 6, 2021 on urgent solutions for COVID-19 prevention and control to implement resolution No 30/2021/QH15 dated July 28, 2021 of the 1st session of the 15th National Assembly. If necessary, the person having the power to establish and assign tasks of COVID-19 treatment shall assign an agency or a public service provider to be responsible for the management and administration of treatment facilities (hereinafter referred to as “host hospital”).

Article 2. Mechanisms and policies on production, import and supply of drugs in the situation of COVID-19 epidemic

1. The legal documents of an application for issuance of the license to import drugs and medicinal ingredients that directly serve the COVID-19 prevention and control without the certificates and consular legalization in accordance with regulations shall be replaced with one of the following information and documents:

a) Information on the website of the Stringent Regulatory Authorities (SRA) that are declared by the World Health Organization (WHO)

b) Certificates of foreign diplomatic missions in Vietnam or competent agencies that are responsible for granting legal documents according to the requests of the Ministry of Health.

2. The production licenses of raw material production facilities specified at Point g, Clause 2, Article 85 of the Government's Decree No. 54/2017/ND-CP dated May 8, 2017 on guidelines for implementation of the Law on pharmacy (hereinafter referred to as “Decree No. 54/2017/ND-CP”) shall be replaced with the certificate of Good Manufacturing Practices (GMP).

3. The Ministry of Health can license to import vaccines that the WHO have approved of use in emergency or urgent cases without approval procedures specified at point c, clause 1 and submission of documents specified at point c, clause 2, Article 67 of Decree No. 54/2017/ND-CP that was amended from the Government's Decree No.155/2018/ND-CP dated November 12, 2018 on amendments to some articles related to business conditions under state management of the Ministry of Health (hereinafter referred to as “Decree No. 155/2018/ND-CP”).

4. The Ministry of Health can license to import vaccines that the WHO and countries of Stringent Regulatory Authorities (SRA) have approved of use in emergency or urgent cases from donating - countries without procedures specified at point c, clause 1 and documents specified at point c, clause 2, Article 67 of Decree No. 54/2017/ND-CP that was amended from the Decree No.155/2018/ND-CP.

5. The vaccines that are aided by the Governments of donating-countries and have been granted license to import in cases of emergency or urgency do not need the dossiers on the summary of production and inspection of the quality of vaccine shipment, certificates of the quality of the competent authorities of the exporting and donating-countries in case of assessment for the purpose of issuance of factory certificates.

6. The declaration and notification of the prices of vaccines that are purchased from the state budget and the COVID-19 vaccine fund for the purpose of the vaccine free of charge to people shall be done according to the following contents:

a) Importing enterprises and units shall declare the prices of vaccines according to the prices stated in signed contracts or agreements without declaration on the pricing elements in accordance with regulations of Law;

b) The Ministry of Health shall report information about prices that enterprises and units sign contracts or agreements to purchase vaccines to the Government without declaration on prices in accordance with law.

7.  The procedures for import of COVID-19 drugs and vaccines that are purchased from the state budget, the COVID-19 vaccine fund or aid/sponsorship:

a) The importing units shall register customs declaration form and preserve goods at warehouses that meet requirements for Good Storage Practices (GSP) declared by the Ministry of Health on its website in conformity with the storage conditions on the labels of shipments of drugs and vaccines while waiting for the approval from Ministry of Health for urgent needs for COVID-19 prevention and control or granting the import licenses according to the requests of the Ministry of Health or the importing units. The customs authorities shall only allow clearance of shipments of drugs and vaccines if the importing units submit the import licenses issued by the Ministry of Health for granting shipments;

b) The importing units shall:

- Report the opening of the customs declaration to the Ministry of Health within 02 working days from the time on which the importing units register customs declaration forms .

- Carry out the procedures for request for granting the import licenses in accordance with regulations. Submit import licenses to customs authorities within 30 working days from the time on which the importing units register customs declaration forms. In case the import license is not granted after the time was over, the Ministry of Health shall send written notification to the customs authorities for management and supervision.

- Preserve the original condition and only allow circulate products after the products are cleared and have certificates of release of vaccines and biological products in accordance with the Law on Pharmacy.

Article 3. Implementation 

1. The Ministry of Health shall take responsibility and cooperate with relevant agencies for the purpose of implementation of this Resolution. In the process of implementation, The Ministry of Health shall use forms of decisions, directives, telegrams, official dispatches and other forms of documents according to their competence in order to prescribe and implement the contents specified in this Resolution.

2. The Ministry of Public Security shall:

a) Direct the local police to cooperate with treatment facilities in assurance about the public security and management of people who are confirmed COVID-19 inspection at these facilities;

b) Direct local fire prevention and fighting forces to cooperate with governing body in assurance about fire prevention and fighting conditions for treatment facilities.

3. The Presidents of the People’s Committees of provinces:

a) Pursuant to the response plan for each epidemic level in order to determine the quantity and promptly establish COVID-19 treatment facilities specified in this Resolution and the instructions of the Ministry of Health of Vietnam.

b) Direct departments and provincial authorities to ensure operation conditions of treatment facilities.

Article 4. Cooperation in implementation

The Central Committee of the Vietnamese Fatherland Front of Vietnam, the Central Committees of socio-political organizations and member organizations of the Front shall carry out dissemination of information and monitor the implementation of this Resolution, be responsible for mobilizing social resources in order to prevent and overcome the damage caused by the COVID-19 epidemic.

Article 5. Implementation provision

1. This Resolution comes into force from the date of signing to the end of December 31, 2022.

2. The regulations of Clause 2, 3 Article 2 of this Resolution comes into force from January 01, 2021

Article 6. Responsibility of implementation

The Ministers, Heads of the Ministerial-Level agencies, Heads of the governmental agencies, the Presidents of the People's Committees of provinces shall be responsible for the implementation of this Resolution